title: Long-term randomized controlled trial of a novel nanopowder hemostatic agent (TC-325) for control of severe arterial upper gastrointestinal bleeding in a porcine model.
abstract: OBJECTIVE
  Endoscopic therapy of brisk upper gastrointestinal bleeding remains challenging. A proprietary nanopowder (TC-325) has been proven to be effective in high pressure bleeding from external wounds. The efficacy and safety of TC-325 were assessed in a survival gastrointestinal bleeding animal model.
  
  
  METHODS
  10 animals were randomized to treatment or sham. All animals received intravenous antibiotics, H2-blockers and heparin (activated clotting time 2 × normal). In a sterile laparotomy the gastroepiploic vessels were dissected, inserted through a 1-cm gastrotomy, and freely exposed in the gastric lumen, and the exposed vessel lacerated by needle knife. The treatment group received TC-325 by a modified delivery catheter while the sham group received no endoscopic treatment. Time to hemostasis, and mortality at 60 minutes, 24 hours, 48 hours, and 7 days were noted. Necropsy was performed in all animals.
  
  
  RESULTS
  Spurting arterial bleeding was achieved in all animals. No control animal showed hemostasis within the first hour compared with 100 % (5 / 5) in the treatment arm (mean 13.8 minutes, P < 0.0079). Durable hemostasis was achieved with no evidence of rebleeding after 1 and 24 hours in 80 % (4 / 5) of the treated animals compared with none in the control group ( P < 0.0098). None of the control animals survived more than 6 hours. Necropsy at 1 week in treated animals revealed healed gastrotomy without foreign body granuloma or embolization to the lung or brain.
  
  
  CONCLUSIONS
  TC-325 is safe and highly effective in achieving hemostasis in an anticoagulated severe arterial gastrointestinal bleeding animal model.
authors.affiliation: Division of Gastroenterology and Hepatology, Johns Hopkins University School of Medicine, Johns Hopkins Hospital, Baltimore 21205, USA. sgiday1@jhmi.edu
authors.forename: S A
authors.initials: SA
authors.lastname: Giday
authors.forename: Y
authors.initials: Y
authors.lastname: Kim
authors.forename: D M
authors.initials: DM
authors.lastname: Krishnamurty
authors.forename: R
authors.initials: R
authors.lastname: Ducharme
authors.forename: D B
authors.initials: DB
authors.lastname: Liang
authors.forename: E J
authors.initials: EJ
authors.lastname: Shin
authors.forename: X
authors.initials: X
authors.lastname: Dray
authors.forename: D
authors.initials: D
authors.lastname: Hutcheon
authors.forename: K
authors.initials: K
authors.lastname: Moskowitz
authors.forename: G
authors.initials: G
authors.lastname: Donatelli
authors.forename: D
authors.initials: D
authors.lastname: Rueben
authors.forename: M I
authors.initials: MI
authors.lastname: Canto
authors.forename: P I
authors.initials: PI
authors.lastname: Okolo
authors.forename: A N
authors.initials: AN
authors.lastname: Kalloo
mesh_terms: D000818:Animals; D005260:Female; D024405:Gastroepiploic Artery; D006471:Gastrointestinal Hemorrhage / Q000628:therapy*; D006490:Hemostatics / Q000008:administration & dosage*; D053758:Nanoparticles; D011208:Powders / Q000008:administration & dosage*; D034421:Sus scrofa
chemical_list: D006490:Hemostatics; D011208:Powders